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U.S. Department of Health and Human Services

Class 2 Device Recall Apollo XT Suture Anchors

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  Class 2 Device Recall Apollo XT Suture Anchors see related information
Date Initiated by Firm January 22, 2018
Create Date July 13, 2018
Recall Status1 Terminated 3 on April 09, 2021
Recall Number Z-2430-2018
Recall Event ID 80069
510(K)Number K142230  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product Apollo XT Suture Anchor, 5.5 x 15

Product Usage:
Apollo XT Suture Anchors are intended for: Shoulder - Rotator Cuff Repair - Bankart Repair - SLAP Lesion Repair - Biceps Tenodesis - Acromio-Clavicular Separation Repair - Deltoid Repair - Capisular Shift or Capsulolabral Reconstruction Foot/Ankle - Lateral Stabilization - Medial Stabilization - Achilles Tendon Repair Knee - Medial Collateral Ligament Repair - Lateral Collateral Ligament Repair - Posterior Oblique Ligament Repair - Illiotibial Band Tenodesis Elbow - Biceps Tendon Reattachment - Ulnar or Radial Collateral Ligament Reconstruction Hip - Capsular Repair - Acetabular Labral Repair
Code Information Model No. XT-5515, Lot No. 2358, 2362, 2363
Recalling Firm/
Manufacturer		 Valeris Medical, LLC
200 Cobb Pkwy N Bldg 200 Ste 210
Marietta GA 30062-3500
For Additional Information Contact Ed James
888-404-3980 Ext. 104
Manufacturer Reason
for Recall		 The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the anchor screw material was titanium, however that part number is made of PEEK.
FDA Determined
Cause 2		 Process control
Action Valeris Medical notified customers on approximately 01/20/2018 via phone call, text, or email. A formal letter was mailed to customers on 02/09/2018. The letter identified the affected product, problem and actions to be taken. Customers were instructed to remove affected products from inventory to quarantine, affix replacement labels provided by Valeris over the current labeling, and notify any customers if product was further distributed to so the product can be quarantined and returned for labeling. Additionally, Valeris requested confirmation in writing that the field correction action has been completed.
Quantity in Commerce 113 units
Distribution US Nationwide Distribution in the states of California and Oklahoma.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = Valeris Medical
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